MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS E8213 manufactured by Gyrus Acmi, Inc.
[139465765]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[139465766]
Olympus received a medwatch report that states during an unspecified procedure, the bladder biopsy forceps broke inside the patient's bladder. The surgeon irrigated the bladder with sorbitol. The surgeon then examined the patient? S bladders and there was no harm and no pieces of the instrument retained. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00555 |
| MDR Report Key | 8430852 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | USA ELITE RIGID OPTICAL TEARING CUP BIOPSY FORCEPS |
| Generic Name | TEARING CUP BIOPSY FORCEPS |
| Product Code | GEN |
| Date Received | 2019-03-18 |
| Model Number | E8213 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |